Cleared Traditional

K955021 - QUANTA LITE PR3

K955021 is the FDA 510(k) clearance for QUANTA LITE PR3 by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MOB) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K955021 · Inova Diagnostics, Inc. · Immunology device
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Mar 1996
Decision
138d
Days
Class 2
Risk

K955021 is an FDA 510(k) clearance for the QUANTA LITE PR3. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 19, 1996 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K955021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1995
Decision Date March 19, 1996
Days to Decision 138 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 104d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 35
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K955021.
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · Zeus Scientific, Inc. · Apr 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · Zeus Scientific, Inc. · Apr 1997
NOVA LITE ANCA
K961340 · Inova Diagnostics, Inc. · Jul 1996
QUANTA LITE MPO
K955022 · Inova Diagnostics, Inc. · Mar 1996
VARELISA PR3-ANCA
K953586 · Elias U.S.A., Inc. · Jan 1996
VARELISA MPO-ANCA
K953587 · Elias U.S.A., Inc. · Jan 1996